Today, May 11, in the Clinical Trial Supply USA 2021 – Virtual Conference, the President and CEO of stem cell biotechnology company Asymmetrex, James L. Sherley, M.D., Ph.D., discussed new developments on the horizon for the supply chains for stem cell therapy and gene therapy clinical trials. In particular, he suggested that it is inevitable that regulatory agencies like the FDA and clinical trial sponsors will eventually require stem cell dosage data for all supply chain activities, as well as for stem cell treatments.
Leading off this morning’s presentations in the Clinical Trial Supply USA 2021 – Virtual Conference, in the Clinical Trial Logistics track, was James L. Sherley, M.D., Ph.D., President and CEO of Massachusetts stem cell biotechnology company Asymmetrex. Dr. Sherley has been a regularly featured expert speaker on the topic of stem cell therapy and gene therapy clinical trial supply in several past conferences organized by Arena International, both virtual and physical.
In his presentation today, “Stem Cell Therapy Clinical Trial Supply: What’s on the Near Horizon?”, Sherley discussed new developments in technical innovation, regulatory agency environment, and clinical sponsor needs that will impact the companies that form the supply chains for stem cell therapy and gene therapy clinical trials. His particular focus was the importance of new innovation for determining the stem cell dosage of stem cell and gene therapy products in the supply chain. Asymmetrex is the first provider of technologies for determining the stem cell dosage of stem cell supply chain products and the treatments developed using them.
For the past 60 years of stem cell medicine, there was no convenient and practical method for determining the dosage of stem cell treatments. Included in these treatments are gene therapy and gene editing therapies that must target tissue stem cells to achieve effective cures that are long-lasting. Of course, for any type of medicine, knowing the dosage is important.
Very recently (2019), new methods have become available that provide routine and reliable determination of the stem cell dosage of stem cell medical products and treatments. In his talk today, Sherley introduced the availability of Asymmetrex’s kinetic stem cell (KSC) counting technology for this purpose. He described it as “A solution on the present horizon.” He discussed how KSC counting addresses a “needed standard” listed by the FDA’s Standards Coordinating Body in a 2020 regenerative medicine report, and more importantly, would improve the effectiveness of stem cell treatments and gene therapies for patients.
Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The company’s U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems – production and quantification – that have stood in the way of effective use of human adult tissue stem cells for regenerative medicine and drug development. Asymmetrex markets kinetic stem cell (KSC) counting, the first technology for determination of the dose and quality of tissue stem cell preparations for use in stem cell transplantation therapies and pre-clinical drug evaluations. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA (ARMI) and the Massachusetts Biotechnology Council (MassBio).